Compositions for Treatment of Attention Deficit Hyperactivity Disorder
AssigneeIronshore Pharmaceuticals & Development, Inc.
InventorsDavid Lickrish, Feng Zhang
Life of this patent
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Abstract
Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.
Claims28
A solid, oral pharmaceutical composition comprising a plurality of particles, each comprising:
- a core comprising methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient;
- a sustained release layer enclosing the core;
- and
- a delayed release layer enclosing the sustained release layer,
- wherein when the composition is orally administered to a human subject, there is a lag period of at least 5 hours during which the plasma concentration of methylphenidate or a pharmaceutical salt thereof is less than 10% of the maximum concentration (Cmax) and wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration.
A water soluble capsule containing a unit dose of methylphenidate or a pharmaceutical salt thereof, wherein when the composition is orally administered to a human subject, there is a lag period of at least 5 hours during which the plasma concentration of methylphenidate or a pharmaceutical salt thereof is less than 10% of the maximum concentration (Cmax) and wherein the time to Cmax (Tmax) is between 12 and 19 hours after administration.
A solid, oral pharmaceutical composition comprising a plurality of particles, each particle comprising:
- a substantially spherical core comprising a therapeutic amount of methylphenidate or a pharmaceutical salt thereof and at least one pharmaceutically acceptable excipient;
- a sustained release layer enclosing the core and comprising ethylcellulose, hydroxypropylcellulose, dibutyl sebacate and from 25-50% magnesium stearate;
- and
- a delayed release layer enclosing the sustained release layer and comprising methacrylic acid copolymer B, mono- and di-glycerides and polysorbate 80.
Dependencies are inferred from the claim text.